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Use innovative regulatory approaches and provide strategic regulatory guidance for assigned projects/products. Develop and implement regulatory strategies, integrating inputs from regulatory team and cross functional partners to build globally aligned
You will act as a trusted quality and compliance advisor. You will help teams navigate complex regulatory requirements, strengthen quality processes, manage risk and continuously improve the way clinical trials are delivered. Monitor the regulatory
Drive biomarker testing strategies across multiple clinical trial programs as well as diagnostic and companion diagnostic (CDx) initiatives; Act as a scientific expert in selecting fit-for-purpose analytical technologies such as LC-MS...
Support the Head of Global Ops, Regions & QM and Regional PV Leads in the oversight, harmonization and maintenance of Regional PV activities, processes and deliverables. Contribute to the establishment and maintenance of the applicable pharmacovigilance
Responsible for leading non‑clinical and early clinical pharmacology strategy across drug development programs. Provides expertise in PK/PD, modeling & simulation, and Model‑Informed Drug Development (MIDD) to support dose selection, study design, and